EFFEKTIVNOST' PRIMENENIYa PREPARATOV OMNIK I OMNIK OKAS U PATsIENTOV S SIMPTOMAMI NIZhNIKh MOChEVYVODYaShchIKh PUTEY NA FONE DOBROKAChESTVENNOY GIPERPLAZII PROSTATY (MNOGOTsENTROVAYa NABLYuDATEL'NAYa PROGRAMMA)


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Resumo

Aim. To investigate the effectiveness and safety of six-month treatment course of Omnic and Omnic Ocas in patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in a routine urology practice in Kazakhstan. Design. This was a multicenter prospective observational program involving the collection of data from patients with LUTS caused by BPH, who received Omnic Ocas or Omnic as the first line treatment. Materials and methods. The program comprised 1513 patients with a verified diagnosis of LUTS/BPH, who received Omnic Ocas or Omnic (tamsulosin) administered by urologists at hospitals in the Republic of Kazakhstan. According to the program protocol, 1381 patients completed the study. The mean age of the patients was 63 years. The study program involved three follow-up visits: Visit 1 (baseline), during which the patient completed the IPSS questionnaire concerning urinary symptoms and quality oflife. After that they underwent a baseline examination including maximum urinary flow rate (Qmax) measured by uroflowmetry, prostate volume determined by digital rectal examination and the serum PSA level. Visit 2 and Visits 3 were scheduled on average at three and six months after Visit 1, respectively, and aimed at assessing the treatment outcomes during the follow-up. Results. During the 6-month treatment, patients of different age groups reported an improvement in the prostate symptom score (IPSS). The drug therapy was more effective in patients with a flow rate of <10 ml/s. There was a gradual decrease in the mean scores of both the storage and voiding I-PSS subscales. Uroflowmetry at six months showed a clinically significant increase in the urinary flow rate. Adverse events were reported by1.9% of patients.

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Sobre autores

B. Shalekenov

Kazakh Medical University of Continuing Education

Email: prof.s.bulat@gmail.com
Dr.Med.Sci., Prof., Head of the Department of Urology and Andrology Almaty, Kazakhstan

Y. Kuandykov

Kazakh Medical University of Continuing Education

Email: erlan_kuandykov@mail.ru
Dr.Med.Sci., Associate Professor at the Department of Urology and Andrology Almaty, Kazakhstan

S. Shalekenov

Kazakh Medical University of Continuing Education

Ph.D., Associate Professor at the Department of Urology and Andrology Almaty, Kazakhstan

Bibliografia

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  6. Michel M.C. et al. Cardiovascular Safety of the Oral Controlled Absorption System (OCAS) Formulation of Tamsulosin Compared to the Modified Release (MR) Formulation. Eur Urol. 2005 ;4(2 Suppl):53-60.
  7. Chapple C.R. et al. Tamsulosin Oral Controlled Absorbtion System (OCAS) in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH): Efficacy and Tolerability in a Placebo and Active Comparator Controlled Phase 3a Study. Eur Urol. 2005;4(2 Suppl):25-32.
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  9. Шатылко Т.В. Использование урофлоуметрии в диагностике и оценке эффективности лечения урологических заболеваний. Бюллетень медицинских интернет-конференций. 2012;2(2):137

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